Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

Phase 3 Completed 425 enrolled Insmed Incorporated

RandomizedParallel-groupDouble-blindTreatment

Summary

The main objective of this study is to evaluate the efficacy of ALIS (amikacin liposome inhalation suspension) + background regimen (azithromycin \[AZI\] + ethambutol \[ETH\]) compared to the ELC (empty liposome control) + background regimen on participant-reported respiratory symptoms at Month 13.

Timeline

Start: 2021-04-01
Primary completion: 2025-11-21
Completion: 2026-01-15

Publications

Mange KC, Serrano D, Hassan M, Nevoret ML, Yuen DW, McManus S, Podger L, Barnes B, Daley CL. Psychometric validation of the PROMIS Fatigue-Short Form 7a in adults with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung disease: the ARISE and ENCORE studies. J Patient Rep Outcomes. 2025 Oct 16;9(1):119. doi: 10.1186/s41687-025-00944-8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ALIS	Unknown	590 mg	Inhaled
Background	Azithromycin	Small molecule	250 mg	Oral
Background	Ethambutol	Small molecule	15 mg/kg	Oral

Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

Summary

Timeline

Publications

Drugs

Indications